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U.S. Department of Health and Human Services

Class 2 Device Recall uMI 550 PET/CT System

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  Class 2 Device Recall uMI 550 PET/CT System see related information
Date Initiated by Firm August 26, 2019
Create Date April 15, 2020
Recall Status1 Terminated 3 on May 18, 2022
Recall Number Z-1708-2020
Recall Event ID 85340
510(K)Number K182237  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Code Information Serial Numbers: 200017 and 200023
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
For Additional Information Contact Shanghai United Imaging Healthcare Co., Ltd.
832-6692799
Manufacturer Reason
for Recall		 Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
FDA Determined
Cause 2		 Software design
Action On August 26, 2019, the firm emailed consignee an "Customer Notification" recall letter. In addition to informing consignees about the recall letter, the notification ask consignees to take the following actions: 1. If the user finds that PET reconstruction failing, the PET should be rescanned immediately to complete a new reconstruction. 2. If this occurs, please contact the UIH Solutions (UIHS) customer Contact Center at telephone numbers (855) 221-1552 (toll free) or (832) 699-2799 (direct) to report the issue.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the state TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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